In today’s healthcare world, cancer treatment remains tied to traditional, expensive, and debilitating methods of chemotherapy and radiation. Oftentimes, patients are monitored at infrequent rates and treated aggressively and with little
attention to impact on other facets of health. Some patients are unable to progress with treatment because of the overwhelming side effects and others cannot afford the care; still others find treatments to be futile in the face of their
rapidly worsening conditions. Many recovered patients undergo the physically and financially draining treatment process, only to find that their cancers had returned to significant extents years later when a relapse could have been
stopped if detection was earlier and more routine. Alternative methods such as immunotherapy are incredibly steep in price, remaining available only to the affluent.
In making Lumicure, the Cornell iGEM team wanted to create a product that attempts to tackle all of the barriers and dilemmas cancer patients face today, from treatment cost to efficacy to screening frequency. Lumicure’s components,
Trichoscan and Trichotherapy, represent revolutionary diagnostic and cancer therapeutic protocols that harness the power of the novel field of bacteriotherapy to produce an affordable, reliable and effective cancer therapy supplement that
may eventually become a primary form of treatment in the near future. Lumicure is a project that is rooted in a dream for more progressive cancer treatment and driven by a trust and acknowledgement of how synbio can help achieve it.
Lumicure is a low toxicity, high-specificity treatment for targets that are most deleterious to fast-growing cancer cells. Our system employs a prolonged treatment effect, rather than a single-time drug delivery mechanism. This means that
the patient will only incur the one-time cost of implementing the system, rather than individual, expensive doses.
Because of its adaptive nature, bacteriotherapy also treats and tracks metastatic cancer more effectively than current therapies. Although metastases are not always detected through a CT scan, they can still be treated by Lumicure because
the bacteria can settle into smaller tumors and produce the therapeutic protein Trichosanthin as well as the mCardinal signaling molecule. Our treatment also uses a sophisticated, non-invasive method to detect the E. coli in the body
through fluorescence detection.
Universal acceptance of bacteria as a treatment medium stands as a barrier to the use of our system. Despite recent advances in the field, bacteriotherapy remains a novel and experimental form of treatment. Much more research and testing
must be performed on a clinical level before bacteriotherapy can be considered as a safe and viable standalone alternative; as such, Lumicure currently remains a supplementary treatment system.
Bacteriotherapy treatments also currently face some limitations in their applicability. Effective usage of Lumicure requires the tumor to be significant in size before the treatment can be employed. Additionally, the treatment may be
limited to a small range of cancers with a certain genetic composition and/or location in the body.
Lumicure’s bacteriotherapy treatment is a viable alternative to late stage treatment drugs, most of which have significant levels of toxicity, and many detrimental side effects. Because of the cell-specific action of Lumicure bacteria
(hypoxic tumor sites) and the low toxicity of the drug Trichosanthin to non-cancer cells, Lumicure and future bacteriotherapy systems represent a risk-free future for cancer treatment.
The population of patients in need of cancer treatment is ever-growing, and the cost of cancer therapeutics is constantly increasing as well. With its low frequency administration model, Lumicure may be able to outpace other forms of
cancer treatment by saving on expenses and increasing accessibility. There is also the possibility of expanding Lumicure to treat other types of cancers, such as colon cancer, brain cancer, and liver cancer.
In order to emerge on the current market of cancer therapeutic systems, Lumicure and its associated components will have to be approved by the FDA and go through an extensive patenting process. This process typically takes 8-10 years, and
involves multiple phases that require sequential approval through vigorous examination. After approval, additional measures need to be taken to approve Lumicure as a government-backed subsidized treatment rather than as a privatized
company brand (which will result in the treatment cost being too high for most patients).
Furthermore, improving tumor detection mechanisms throughout the industry have also curbed the need for mixed diagnostic-delivery systems like those employed by Lumicure’s Trichotherapy/Trichoscan combination. There is a possibility that
such a system may be financially unviable due to additional unforeseen costs in developing complementary services such as ways of administering the bacteria and imaging devices.
|
|
|||||||||||||||||||||||||||||||||||||||
|
|
In a study comparing the treatment costs for breast cancer, it was found that average costs allowed per patient in the 24 months after the index diagnosis were $71,909, $97,066, $159,442, and $182,655 for disease stage 0, I/II, III, and IV, respectively. As a supplement, Lumicure represents less than 1% of the total yearly cost of treatment at each of the stages for 1 usage and personal scanning unit.
Cornell University facilitates licensing of research produced by students and CU iGEM will likely pursue patents for the components of the Lumicare system for future collaboration and expansion. For example, a patent could be pursued for
the engineered bacteria as well as the Trichoscan hardware system built to enhance cancer detection. Filing for such patents would be performed through the Cornell Center for Technology Licensing (CTL).
In terms of the product life cycle, Lumicure is still in the first stage of development. A foreseeable course of action for post-competition product would be as follows:
- Patent approval: secure patents for the engineered bacteria and PD system through the FDA. This process, which involves non-human experimentation, clinical trials and pre-approval measures, will span 8-10 years.
-
Introduction phase: heavy investments into advertising and a promotion campaign will help introduce the public to the concept of bacteriotherapy. This awareness movement will center around how treatment is administered and its benefits when compared to other breast cancer treatments.
At this stage, the customer base would consist of innovators and early adopters, as bacteriotherapy is a very new treatment that has yet to be widely accepted in the medical field. - Growth: is expected to occur after raising public awareness, successfully treating patients and developing enough funding and backing to distribute Lumicure on a national level. Reflected by growing demand, increases in production, and expansion of availability. Lumicure would become widely accepted as a viable alternative to more commonplace breast cancer treatments like surgery and chemotherapy.
Given that Lumicure is a theoretical demonstration of a therapeutic avenue for cancer treatment, CU iGEM will likely implement a partnership growth strategy in the short term, whereby our team can provide information and expertise to companies looking to develop similar products. This is a low risk, low reward growth tactic, but has great potential to facilitate a commercial product based on Lumicure’s prototype. Before the lengthy patenting process for Lumicure itself can be completed, our collaboration with other like-minded organizations can plant the seeds for the standardization of cancer bacteriotherapy treatment in the future.
The ultimate goal of CU iGEM’s Lumicure project is to come up with a bacteriotherapy treatment that is as affordable and as accessible of a product as possible. Therefore, realizing our long term goal involves patent approval with the FDA and negotiations with governments and healthcare organizations to subsidize the market-ready design. CU iGEM’s objective is for Lumicure to provide a cheaper and more valuable method of cancer treatment than current solutions, whether it remains as an auxiliary treatment or becomes a primary one.